ORCA-DX BONE DENSITOMETER

K983724 · Lunar Corp. · KGI · Dec 8, 1998 · Radiology

Device Facts

• Record ID: K983724
• Device Name: ORCA-DX BONE DENSITOMETER
• Applicant: Lunar Corp.
• Product Code: KGI · Radiology
• Decision Date: Dec 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm. The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns. The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement: "Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

Device Story

ORCA-DX Bone Densitometer uses dual-energy x-ray absorptiometry to estimate bone mineral density (BMD) in heel and forearm. Device requires 4-second x-ray exposure (<10 mrem dose). System provides BMD output (g/cm2) for clinical assessment. Used in clinical settings by trained operators under physician order. Output assists healthcare providers in evaluating bone health. Benefits include non-invasive BMD estimation with low radiation exposure.

Clinical Evidence

Bench testing only. In vivo short-term BMD precision (%CV) is <1.5%. BMD estimations correlate ~0.95 with results from the predicate device.

Technological Characteristics

Dual-energy x-ray absorptiometry system. Requires 4-second exposure; total dose <10 mrem. Measures heel and forearm BMD. Standalone device.

Indications for Use

Indicated for estimation of bone mineral density (BMD) in the heel and forearm. Restricted to prescription use by or on the order of a physician.

Regulatory Classification

Identification

A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• LUNAR PIXI (K970224)

Submission Summary (Full Text)

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K983724

Image /page/0/Picture/1 description: The image shows the text "DEC 8 1998" at the top and the word "LUNAR" in large, bold, black letters below it. The text "DEC 8 1998" is smaller and less prominent than the word "LUNAR". The overall impression is that the image is a logo or heading for something related to the word "LUNAR".

MADISON, WI 53713 313 W. BELTLINE HIGHWAY

[phone]

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

| Contact Person: | Kenneth D. Buroker |
|----------------------|---------------------------|
| | LUNAR Corporation |
| | 313 West Beltline Highway |
| | Madison, WI 53713 |
| Phone: | [phone] |
| Fax: | [phone] |
| Date: | October 21, 1998 |
| Device/Trade Name: | ORCA-DX Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer |
| | 21CFR 892.1170 |
| Predicate Device: | LUNAR PIXI |
| | 510(k) k970224 |

#### 10.1 DESCRIPTION OF THE DEVICE

The ORCA-DX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) for the heel and forearm, using dual-energy x-ray absorptiometry.

### SUMMARY OF TECHNICAL CHARACTERISTICS 10.2

The ORCA-DX® Bone Densitometer requires a 4-second exposure, with a total exposure dose of <10 mrem. The radiation exposure of <10 mrem is lower than that for the predicate device and is low compared to the maximum permissible dose for extremities. The BMD estimations correlate ~0.95 with results obtained on the predicate device. The short-term BMD precision (%CV) in vivo is <1.5% and is comparable to previously registered devices.

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Summary of Safety and Effectiveness Page 2 of 2

## 10.3 CONCLUSION

The results from the ORCA-DX Bone Densitometer are comparable to previously registered devices that demonstrate similar precision. No new safety and effectiveness questions are raised with the ORCA-DX Bone Densitometer.

Signature

Kenneth D. Buroker
Printed Name

Director, Regulatory Affairs
Title

10/21/98
Date

Date

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1098 8 DEC

Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713

K983724 ORCA-DX Bone Densitometer Dated: October 21, 1998 Received: October 22, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI

Dear Mr. Buroker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrfvdsmardsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATION FOR USE FORM 3.0

Page 1 of 1

- 510(k) Number (if known) __ .
- Device Name: ORCA-DX® Bone Densitometer .
- Indications for use: .

The ORCA-DX® Bone Densitometer provides an estimate of BMD for the heel and forearm.

The ORCA-DX® Bone Densitometer requires a 4-second exposure for BMD with a skin entrance dose of <10 mrem. This instrument is comparable to the Lunar PIXI densitometer. The ORCA-DX® Bone Densitometer poses no new safety or efficacy concerns.

The use of the ORCA-DX® Bone Densitometer is restricted to prescription use only. The operator's manual for the system contains the following statement:

> "Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."

# PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Vinnit li. Sezmm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number